Highly efficient filter for cleanrooms class A according to gmp

New offers are constantly appearing on the market for air filtration systems for clean rooms. Often, promises to achieve the level of purity required to meet GMP (Good Manufacturing Practice) requirements sound overly optimistic. Many manufacturers, in an effort to maximize profits, simplify technological solutions, which usually leads to problems with reliability and efficiency in real-world operating conditions. It is important to understand that simply having a certificate does not guarantee compliance - a comprehensive approach is required, including choosing the right filter, correct installation and subsequent maintenance.

What does 'high efficiency' and 'class A' mean in cleanroom filters?

Perhaps most important is to properly understand what is meant by the terms 'high efficiency' and 'Class A' in the context of cleanroom filters. 'Highly efficient' refers to the filter's ability to capture the smallest particles of dust and contaminants. In cleanrooms, especially in pharmaceutical and biotech applications, this is critical. Often, manufacturers indicate efficiency (for example, HEPA filters with an efficiency of 99.97% for particles 0.3 microns in size). But, as a rule, this applies to *certain* types of particles, and does not always reflect the actual picture in the room.

Cleanliness Class A (Class A) is the highest cleanliness class in the ISO 14644 classification system. It implies a minimum number of particles of 0.5 microns in size per unit time. Achieving Class A requires not only an effective filter, but also strict control over all aspects of the environment: from the ventilation system to the work practices of personnel. Often, 'Class A' is mentioned in marketing materials without sufficient explanation as to how it is achieved. And this is where the problems begin. It has even been seen that laboratories requiring class A purity ended up with unsatisfactory measurement results because the actual operating conditions did not correspond to the declared ones. This, of course, requires detailed analysis and understanding of all factors.

Types of filters used to achieve GMP-compliant purity

There are different types of filters used in cleanrooms, each of which has its own advantages and disadvantages. The main categories are pre-filters, fine filters (usually HEPA or ULPA), and carbon filters (to remove odors and VOCs).

Pre-filters are a rough cleaning of large particles: dust, fibers, insects. They significantly increase the service life of more expensive and sensitive fine filters. It is important to select pre-filters with the appropriate filtration class and replace them regularly. We are at ?Tianjin Tongchang Junqi Cleaning Equipment Co.,Ltd? We recommend using pre-filters with the highest possible efficiency to reduce the load on subsequent filters.

Fine filters (HEPA and ULPA) are the basis of a filtration system for clean rooms. HEPA filters (High Efficiency Particulate Air) filter 99.97% of particles measuring 0.3 microns. ULPA (Ultra Low Penetration Air) filters are even more effective, trapping 99.999% of particles of the same size. The choice between HEPA and ULPA depends on the cleanliness requirements of a particular room. In some cases, the use of ULPA filters may be justified, for example, in the microelectronics industry or when working with biological materials.

Don't forget about carbon filters, which are used to remove odors, volatile organic compounds and other contaminants that affect air quality. This is especially true in the pharmaceutical and chemical industries, where it is important to eliminate the possibility of cross-contamination.

Example of a real problem and its solution: humidity control and decontamination

We once worked with a company that made sterile solutions. They were faced with the problem of mold in the cleanroom, despite the presence of HEPA filters. Upon closer examination, it turned out that the air humidity exceeded the permissible level, which created favorable conditions for the growth of fungus. In addition, equipment was not decontaminated thoroughly enough, and disinfectant particles could settle on surfaces and cause allergic reactions. The solution was to install a humidity control and air decontamination system using ultraviolet lamps and ionizers. The decontamination procedure was also revised and new methods of sterilizing equipment were introduced.

This case showed that to achieve a high level of cleanliness, it is necessary to take into account not only the quality of the filters, but also other factors affecting the condition of the air. Ignoring these factors can lead to serious problems.

Maintenance and monitoring of the filtration system

Regular maintenance and monitoring of your filtration system is essential to maintaining its effectiveness. This includes replacing filters, checking connections for leaks, monitoring air pressure and regularly checking filtration efficiency. We offer maintenance services for cleanroom filtration systems, including filtration efficiency measurements and reporting.

It is important not only to replace filters on schedule, but also to monitor their condition. Signs of filter wear may include discoloration, debris, or decreased air pressure. Regular monitoring allows you to identify problems at an early stage and prevent serious breakdowns. We use state-of-the-art equipment to analyze air and determine filtration efficiency, allowing us to offer the most effective solutions.

Experience of cooperation with the Air Conditioning Research Institute

Our experience with the Air Conditioning Research Institute of the China Institute of Building Sciences has had a significant impact on the development of our technology. Joint developments have allowed us to create filters that meet the highest requirements for purity and efficiency. We participated in the development of the national standard GB/T-13554, which ensures that our products comply with the requirements of Chinese law.

Our filters are constantly being improved based on the latest scientific developments and technologies. We follow filtration trends and introduce new solutions that allow our customers to achieve optimal levels of air purity.

Conclusion: An integrated approach is the key to success

Achieving GMP compliance in cleanrooms is a complex task that requires a comprehensive approach. Choosing the right filter is just one element of this system. It is important to consider all factors affecting air quality and regularly maintain and monitor the filtration system. Tianjin Tongchang Junqi Cleaning Equipment Co., Ltd. offers a wide range of filters and equipment for clean rooms, as well as services for the design, installation and maintenance of filtration systems. We are ready to help you achieve optimal levels of air purity in your premises.